Target Health has been in the software business since 1999 when we started our journey into EDC (15 FDA approvals to date). In addition to EDC, we have built a web-based document system, a clinical trial management system, an encoder for MedDRA and drugs, a pharmacovigilance module for MedWatch and CIOMS, a newsletter etc. Several CROs have already licensed Target Document® and Target e*CTMS™. Our software gives companies the tools they need to execute clinical trials in efficient and cost effective manners. We provide what is needed with the appropriate bells and whistles. What makes us different is that before we would recommend our software to anyone else, the software has to be used by our CRAs and Project and Data Managers first. Since software is not our only business, we are able to provide competitive prices to our customers.

For more information about Target Health and any of our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors

According to an article published in the New England Journal of Medicine (2009;360:1298-1309), men who undergo medical circumcision can significantly reduce their risk of acquiring two common STD infections: herpes simplex virus type 2 (HSV-2), the cause of genital herpes, and human papillomavirus (HPV), which can cause cancer and genital warts. These infections cause genital ulcers and are associated with an increased risk of HIV acquisition. Circumcision had no effect on becoming infected with the bacterium that causes syphilis. These findings build upon earlier clinical research which found that circumcision decreases a man’s risk of acquiring HIV infection by more than 50%. The present study was conducted at the Rakai Health Sciences Program in Uganda in collaboration with the Johns Hopkins University Bloomberg School of Public Health, Makerere University in Kampala, Uganda, and NIAID’s Division of Intramural Research. The study examined samples from two parallel clinical trials in Rakai that successfully proved male circumcision as an HIV prevention method and also assessed the surgical procedure’s ability to prevent other STD infections, including syphilis and HSV-2. The studies enrolled 3,393 uncircumcised men between the ages of 15 and 49 who initially tested negative for both HIV and HSV-2. The men were assigned at random to one of two study groups: 1,684 received immediate circumcision performed by trained medical professionals in an outpatient setting (intervention group); and 1,709 received medical circumcision after a delay of 24 months (control group). The volunteers were evaluated at 6, 12 and 24 months for HSV-2 and syphilis infection. Additionally, a subgroup of 697 volunteers (352 participants in the intervention group; 345 in the control group) was evaluated for HPV infection at enrollment and at 24 months. Results showed that the cumulative probability of HSV-2 infection was significantly lower among those volunteers who received immediate circumcision (7.8%) than among those in the control group who were circumcised at 24 months (10.3%). Overall, the researchers found that medically supervised circumcision reduced the men’s risk of HSV-2 infection by 28%. The combined results from both trials also demonstrated a 35% reduction in HPV prevalence among men in the intervention group. In evaluating a subgroup of volunteers at 24 months, high-risk HPV strains associated with certain cancers were detected in 42 of 233 men in the intervention group and in 80 of 287 men in the control group. Circumcision did not, however, affect the incidence of syphilis. At 24 months, syphilis was detected in 50 men in the intervention group and 45 members of the control group. The biological reasons why circumcision may reduce the risk of HSV-2 and HPV infection, but not syphilis, are not entirely known. HSV-2 and HPV multiply in epithelial cells found in the surface skin, and the foreskin may facilitate virus entry into those cells. Once circumcision has been performed, the risk of epithelial infection may be reduced. Additionally, the analysis used to determine the effects of circumcision on syphilis had limited statistical power, and therefore, it is difficult to draw a firm conclusion as to whether or not circumcision may reduce syphilis incidence.

TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.

The FDA approved IXIARO, a vaccine to prevent Japanese encephalitis (JE) which is caused by a mosquito-transmitted virus found mainly in Asia. In Asia, JE affects about 30,000 to 50,000 people each year, resulting in 10,000 to 15,000 deaths. JE is rarely seen in the US, with very few cases reported among civilians and military traveling from the United States to Asia. The virus that causes JE affects membranes around the brain and mild infections can occur without apparent symptoms other than fever and headache. In people who develop severe disease, JE usually starts as a flu-like illness but can worsen, causing high fever, neck stiffness, brain damage, coma, or even death. The disease is transmitted via infected mosquitoes; it is not spread from human to human. IXIARO will be the only vaccine for JE available in the US. IXIARO is a second-generation JE vaccine, in that it is manufactured using cell culture technology leading to improved manufacturing efficiency as well as more reliable control of the vaccine manufacturing process. This technology utilizes an established bank of cells that can be drawn from at any time contributing to the assurance of consistent vaccine quality. It also enhances the ability to rapidly manufacture a vaccine on a large scale if needed, without compromise to the vaccine’s safety or effectiveness. Clinical studies were conducted in more than 800 healthy men and women in the United States and Europe. Participants received either IXIARO or JE-VAX, another U.S.-licensed vaccine that is no longer being manufactured. The studies found that IXIARO produced sufficient levels of antibodies in the blood to protect against JE. IXIARO requires two doses instead of JE-VAX’s three. The vaccine was well tolerated and the most commonly reported adverse events were headache, muscle pain and pain, swelling, and tenderness at the injection site. Overall, it was more tolerable and had fewer side effects than the comparator, JE-VAX. IXIARO is manufactured by Intercell Biomedical, Livingston, U.K.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

Docosahexanoic acid (DHA), an omega-3 fatty acid found in fish oils, has been shown to reduce the size of 1) ___ and enhance the positive effects of the chemotherapy drug cisplatin, while limiting its harmful side effects. Experiments in the rat have provided some support for the plethora of health benefits often ascribed to omega-3 acids. Professor A. M. El-Mowafy led a team of researchers from Mansoura University, Egypt, who studied DHA’s effects on solid tumors growing in mice, as well as investigating how this fatty acid interacts with cisplatin, a chemotherapy drug that is known to cause 2) ___ damage. El-Mowafy said, “DHA elicited prominent chemopreventive effects on its own, and appreciably augmented those of cisplatin as well. Furthermore, this study is the first to reveal that DHA can obliterate lethal cisplatin-induced nephrotoxicity and renal tissue injury.” DHA is an omega-3 fatty acid that is commonly found in cold-water fish oil, and some vegetable oils. It is a major component of brain gray matter and of the 3) ___ in most mammalian species and is considered essential for normal neurological and cellular developments. According to the authors, “While DHA has been tentatively linked with protection against cardiovascular, 4) ___ and neoplastic diseases, there exists a paucity of research information, in particular regarding its interactions with existing chemotherapy drugs”. The study found that, at the molecular level, DHA acts by reducing 5) ___ (white blood cell accumulation), systemic inflammation, and oxidative stress – all processes that have been linked with tumor growth. El-Mowafy and his colleagues have called for greater deployment of omega-3 in the fight against 6) ___. They write, “Our results suggest a new, fruitful drug regimen in the management of solid tumors based on combining cisplatin, and possibly other chemotherapeutics, with DHA.”

ANSWERS

1) tumors; 2) kidney; 3) retina; 4) neurological; 5) leukocytosis; 6) cancer